Impact of Preoperative Sarcopenia on Morbidity and Mortality in Patients Operated on From Digestive Cancers

NCT02811666 | Unknown

• 1 other identifier: PA16063
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia (loss of muscle mass and function) can be observed at any age and results of multiple factors (age, activity, inflammatory factors, nutritional status...). It deeply impacts the physical performance and the basal metabolism, and induces cardiovascular disorders, dyslipidemia, and diabetes. Sarcopenia appears like an independent factor decreasing the quality of life, exacerbating the toxicity of chemotherapy and increasing mortality for gastrointestinal cancer. However, few studies have demonstrated his impact on postoperative course in digestive oncology. The search for sarcopenia, complementary nutritional status, is now a source of great interest with 62 ongoing projects in the United States. The first objective of this study is to evaluate the impact of preoperative sarcopenia on 30-days morbidity and mortality of patients operated on from poor prognosis gastrointestinal cancer (liver and pancreas). The second objective is to evaluate the impact of preoperative sarcopenia on the long term outcomes (12 months) on the same patients.

Conditions

Sarcopenia; Malnutrition; Pancreatic Cancer; Liver Cancer

Outcome Measures

Primary Outcomes (2)

• muscle surface using CT-Scan

  up to12th month postoperatively

• muscle strength using a hand gauge

  up to12th month postoperatively

Study Arms (1)

Patients operated for liver or pancreas cancer

EXPERIMENTAL

Device: Assessment of sarcopenia by CT-Scan; Device: hand gauge

Interventions

Assessment of sarcopenia by CT-Scan DEVICE

Patients operated for liver or pancreas cancer

hand gauge DEVICE

Patients operated for liver or pancreas cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years
• Patients who agreed to participate in the study
• The patients insured by French health care

You may not qualify if:

• Patients treated by radio-frequency
• Patients operated for extrahepatic cholangiocarcinoma , cancer of the papilla of Vater or the gall-bladder
• Patients with primary peritoneal cancer
• Patients with palliative surgery without resection
• Patients protected by law
• Minor patients

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu de Reims

Reims, France, 51092, France

Location

MeSH Terms

Conditions

Sarcopenia; Malnutrition; Pancreatic Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases

Central Study Contacts

Yohann RENARD

CONTACT

yrenard@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 23, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: June 23, 2016

Record last verified: 2016-06

Locations

FR (1)